Phase 2 Breast Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older
• People with breast cancer that has spread to other parts of the body or cannot be surgically removed
• People whose breast cancer has tested negative for HER2, based on specific laboratory testing results on their most recent tumour sample
• People who have already received at least 2 previous chemotherapy treatments for advanced breast cancer, including at least one antibody-drug treatment — or, if a certain inherited gene mutation (BRCA) is present, a PARP inhibitor treatment (confirm with trial site)
• People whose tumour has a specific type of genetic mutation called a Class IV or V somatic ERBB3 mutation, found through a tumour test done during the trial's screening process
• People whose general health and ability to carry out daily activities meets a standard medical scoring level (ECOG score of 2 or below — confirm with trial site)
• People whose cancer can be measured or detected using standard imaging criteria
• People whose heart is pumping at a sufficient level (at least 50% efficiency), confirmed by a heart scan done within 4 weeks before starting treatment
• People whose kidneys, liver, and other organs are functioning at adequate levels based on recent blood tests
• Women who could potentially become pregnant must have a negative blood pregnancy test within 7 days before starting treatment
• Women who could potentially become pregnant, and men whose partners could become pregnant, must agree to use a highly effective form of contraception during the trial and for 3 months after finishing treatment
• People who, in the treating doctor's opinion, are suitable for the treatment stage of the trial
• People who are covered by a health insurance plan
• People who are able to understand and sign a consent form agreeing to take part

Who may not be able to join:

• People who have previously received any treatment that specifically targets HER2 (note: prior treatment with a medicine called trastuzumab deruxtecan may be allowed in certain HER2-low cases — confirm with trial site)
• People who have had an allergic reaction to trastuzumab, tucatinib, or closely related medicines
• People who are currently pregnant, breastfeeding, or planning a pregnancy from the time of signing consent until 7 months after the last dose of the study drug
• People who cannot swallow tablets or capsules, or who have a significant digestive condition or history of surgery that would prevent medicines from being properly absorbed
• People who have recently taken certain medicines that strongly affect how the body processes drugs (specific types called strong CYP2C8 inhibitors or strong CYP3A4/CYP2C8 inducers) within a defined period before starting treatment — confirm which medicines apply with the trial site
• People who have received any cancer treatment (including hormone therapy), radiation therapy outside the brain, or another experimental treatment within 3 weeks before starting the trial (certain hormone injections called GnRH agonists may be an exception — confirm with trial site)
• People currently taking part in another interventional clinical trial
• People who have brain metastases (cancer spread to the brain) that are causing symptoms and have not been treated, that need urgent treatment, or that require more than a low dose of a steroid medicine called dexamethasone
• People who have had whole-brain radiation therapy within 21 days, or targeted brain radiation within 7 days, before starting treatment
• People whose cancer has spread to the lining surrounding the brain and spinal cord
• People who have had major surgery (including brain surgery) within 21 days before starting treatment
• People who have had another type of cancer within the past 2 years that required systemic treatment
• People who have had a heart attack or unstable chest pain (angina) within the past 24 weeks
• People with significant heart or lung conditions, including: certain abnormal heart rhythms requiring treatment; uncontrolled high blood pressure despite medication; any history of heart failure with symptoms; severe breathlessness at rest; a need for supplemental oxygen (except for sleep apnea); or a certain abnormality on a heart tracing test (ECG) called QTc prolongation at Grade 2 or above
• People with conditions that could lead to a specific type of dangerous heart rhythm problem, including inherited or acquired long QT syndrome, a family history of sudden death, a history of a previous medicine causing QT prolongation, or current use of medicines known to carry this risk
• People known to have active Hepatitis B, Hepatitis C, or another chronic liver disease
• People known to be HIV positive
• People with a mental health condition or altered mental state that, in the treating doctor's opinion, would prevent them from giving valid informed consent
• People who would have difficulty participating in trial procedures for geographic, social, or psychological reasons
• People who are under legal guardianship or whose personal liberty is restricted

Important: Always verify eligibility with the trial site directly before applying.